A randomized double blinded placebo controlled trial of sildenafil for renoprotection prior to hilar clamping in patients undergoing robotic assisted laparoscopic partial nephrectomy

Objective

To perform a randomized control trial (RCT) assessing the effect of phosphodiesterase 5 inhibitor (PDE5i) used prior to hilar clamping during robot assisted partial nephrectomy (RAPN) for renoprotection.

Materials and Methods

We performed an institutional review board approved, placebo controlled, double blinded RCT evaluating a single 100 mg oral dose of sildenafil immediately prior to RAPN. Primary end point was accrual, participation and retention of patients with secondary endpoints assessing post-operative renal functional outcomes and safety. Exclusion criteria included history of coronary artery disease, solitary kidney, suspected benign pathology, PDE5i intolerance or pregnant females.

Results

Of 40 eligible consecutive patients undergoing RPN between 9/2013 and 12/2014, 30 (75%) were randomized to treatment and there was 100% participation and retention. The groups were well matched for all measured comorbidities. Intraoperative outcomes including warm ischemia time (median 15 vs. 16.5 min, P = 0.29) were similar. Change in eGFR demonstrated similar decrease between sildenafil versus placebo at 1 day (−8% vs. −10%, P = 0.53), 2 days (−9% vs. −9%, P = 0.77), and 1 month (−4% vs. −6%, P = 0.31) following RAPN. Intermediate follow up (median 183 days) demonstrated similar results (−8% vs. −1%, P = 0.16) between the two cohorts. Safety profiles were similar between the two cohorts without any adverse reactions to the sildenafil.

Conclusions

Successful retention of patients was achieved in this RCT. The secondary outcome of renoprotection was not identified. J. Surg. Oncol. © 2016 Wiley Periodicals, Inc.

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